RecruitingPhase 2NCT05388773

Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

Phase II Trial of Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

Sponsor

Heath Skinner

Enrollment

150 participants

Start Date

Jul 20, 2022

Study Type

INTERVENTIONAL

Conditions

Oropharynx Cancer

Summary

This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether people with HPV-related throat cancer (oropharynx cancer) that tests positive for the p16 protein can safely receive lower, de-escalated doses of radiation after surgery — reducing long-term side effects like difficulty swallowing and dry mouth — without compromising cancer control. **You may be eligible if...** - Your oropharyngeal cancer was confirmed by biopsy and tests positive for p16 (a marker of HPV-related cancer) - Your cancer has been assessed as surgically removable through the mouth (transoral surgery) - You are in good overall health (able to perform normal daily activities) - You have not received prior radiation to the head and neck area **You may NOT be eligible if...** - Your cancer is fixed to major structures like the carotid artery, skull base, or cervical spine - You require complex reconstructive surgery (microvascular free flap) - You are pregnant - There is evidence that your cancer has spread to distant organs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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